Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT02420002
Eligibility Criteria:
Inclusion Criteria:
* The patient was informed about the implementation of the study, its objectives, constraints and patient rights
* The legal representative of the patient must have given free and informed consent and signed the consent
* The patient must be affiliated with or beneficiary of a health insurance plan
* The patient is available for 15 days of follow-up
* The patient is consulting in the emergency department for a wound requiring the completion of a suture and for which the operator considers that the use of nitrous oxide is necessary and possible.
Exclusion Criteria:
* The patient is participating in another interventional study
* The patient has participated in another interventional study in the last 3 months
* The patient is in an exclusion period determined by a previous study
* The patient and/or his/her parents (or legal representative) refuses to sign the consent
* It proves impossible to correctly inform the patient and / or his/her parents (or legal representative)
* The patient has a contra-indication (or an incompatible drug combination) for a treatment required in this study (MEOPA): intracranial hypertension, impaired consciousness, pneumothorax, high rate oxygen-dependence, facial trauma preventing mask application.
* The patient has a condition that makes hypnosis impossible: e.g. encephalopathy, deafness, communication disorders, does not speak French
* Suture requiring surgical exploration or an operating room, or general anesthesia or an ears-nose-throat, orthopedic or visceral surgeon (e.g. wound of the oral cavity, abdominal or thoracic penetrating wound, finger or palm wound requiring exploration by an orthopaedist)
* Fractures associated with wound
* Use of level II/III analgesics before the beginning of pre-suture care support
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
17 Years
Study:
NCT02420002
Study Brief:
Protocol Section:
NCT02420002